psilocybin (NM-1001) / NovaMentis - LARVOL DELTA

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome (clinicaltrials.gov) - P2 | N=10 | Suspended | Sponsor: Nova Mentis Life Science Corp | Recruiting ➔ Suspended

Trial suspension • Cognitive Disorders • Fragile X Syndrome • Genetic Disorders • FMR1

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Nova Mentis Life Science Corp | Trial primary completion date: Jan 2024 ➔ Apr 2024

Trial primary completion date • Cognitive Disorders • Fragile X Syndrome • Genetic Disorders • FMR1

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Nova Mentis Life Science Corp | Trial completion date: Aug 2023 ➔ Apr 2024 | Trial primary completion date: May 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Cognitive Disorders • Fragile X Syndrome • Genetic Disorders • FMR1

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Nova Mentis Life Science Corp

New P2 trial • Cognitive Disorders • Fragile X Syndrome • Genetic Disorders • FMR1

Wellbeing Subsidiary KGK Science Begins Recruitment in First-of-its-Kind Health Canada Approved Psilocybin Trial (Businesswire) - "Wellbeing Digital Sciences Inc...announces that its wholly owned subsidiary KGK Sciences Inc. has begun recruiting participants, on behalf of client Nova Mentis Life Science Corp....in the first-ever clinical trial investigating the effects of psilocybin on adults diagnosed with fragile X syndrome (FXS), the leading genetic cause of autism spectrum disorder (ASD)....The 28-day study will test the safety and efficacy of Nova Mentis’ proprietary psilocybin drug (NM-1001) for the treatment of FXS and is one of the first Health Canada approved studies allowing participants to take home psilocybin for dosing every other day...The Company anticipates treating their first participant in Q2 2023 and having preliminary results ready later this year."

New P2a trial • Fragile X Syndrome • Genetic Disorders

Psilocybin mitigates the cognitive deficits observed in a rat model of Fragile X syndrome. (PubMed, Psychopharmacology (Berl)) - "These data support the hypothesis that serotonin-modulating drugs such as psilocybin may be useful to ameliorate ASD-related cognitive deficits. Overall, this study provides evidence of the beneficial effects of different schedules of psilocybin treatment in mitigating the short-term cognitive deficit observed in a rat model of FXS."

Journal • Preclinical • Autism Spectrum Disorder • CNS Disorders • Cognitive Disorders • Developmental Disorders • Fragile X Syndrome • Genetic Disorders • Mental Retardation • Psychiatry

"$NMLSF Nova Mentis Completes Production of Psilocybin Microdose Capsules https://t.co/IYGrOfZVeH" (@otcdynamics)

A Novel Psilocybin Microdose Treatment of Fragile X Syndrome (NFXF-FXC 2022) - "The Fmr1-Δexon 8 rat model mimics key autistic-like features in humans and supports an important role for microdose therapy of FXS. The positive response in the rat of every other day oral 0.1 mg/kg psilocybin (equivalent to a 1.5 mg dose in a 70 kg person) may be the treatment of choice to effect behavioral changes and perhaps have a longer term constructive neuroplastic response in the brain."

Fragile X Syndrome • Genetic Disorders

/R E P E A T -- Nova Mentis Expands Pre-Clinical Development Pipeline; Company Begins Fragile X Syndrome Treatment with its Proprietary Psilocybin Drug/ (Canada Newswire) - "Nova Mentis Life Science Corp....is pleased to announce that the Company is expanding its pre-clinical program to develop a novel diagnostic and treatment approach to fragile X syndrome (FXS)...NOVA plans to conduct the FXS study alongside its currently ongoing prenatal valproic acid (VPA) rodent model of ASD with Dr. Trezza. During the treatment phase of the study, NOVA will administer its proprietary psilocybin drug, PLZ-1013 to test its potential efficacy in FXS and to determine therapeutic dosage parameters for planned human studies....'We are delighted to have expanded our pre-clinical development pipeline to treat this unmet medical need, fragile X syndrome.'"

Preclinical • Fragile X Syndrome